Zenotech Laboratories
BSE: 532039 | NSE: N.A | ISIN: INE486F01012 | Pharmaceuticals
- Directors Report
- Chairman's Speech
- Auditors Report
- Notes To Accounts
- Accounting Policy
- Finished Products
- Raw Materials
| Directors Report | Year End : Mar '06 |
Your Directors present the report on the business and operations of the
Company for the year ended March 31st, 2006.
FINANCIAL HIGHLIGHTS
For the year ended
Rs lakhs
2006 2005
Sales 1,319.62 562.27
Otherlncome 8.88 28.62
Gross profit before interest and depreciation 121.51 66.50
Interest 52.76 21.26
Depreciation 25.89 5.89
Amortisation of goodwill and
miscellaneous expenses 97.31 161.72
Extra-ordinary Items-provision for doubtful
debt and write off of investment - 257.34
Profit/(loss) before tax (54.45) (379.72)
Provision for tax (including deferred taxes) 19.36 25.90
Profit/(loss) after tax (73.80) (408.63)
Loss brought forward from previous year (435.88) (27.25)
Loss brought forward from
M/s. Credence Pharmaceuticals Limited and
M/s. Hemarus HealtMcare Private Limited (78.87) -
Profit/(loss) carried forword
to balance sheet (588.56) (435.88)
SCHEME OF AMALGAMATION
During the year, the Company has, pursuant to the provisions of Section
391 to 394 of the Companies Act, 1956 and with the approvals of the
shareholders and secured creditors, entered into a Scheme of
Amalgamation with M/s, Credence Pharmaceuticals Limited and M/s,
Hemarus Healthcare Private Limited. The Honble High Court of Andhra
Pradesh at Hyderabad has sanctioned the Scheme of Amalgamation with
effect from October 1st 2005 through its order dated May 2nd, 2006, The
certified copies of the orders of the Honble High Court were filed
with the Registrar of Companies, Andhra Pradesh on May 25th, 2006,
Hence, the consolidated accounts of M/s, Zenotech Laboratories Limited,
M/s. Credence Pharmaceuticals Limited and M/s. Hemarus Healthcare
Private Limited have been prepared for the year ended as on March 31st,
2006.
CONSOLIDATED FINANCIAL STATEMENTS
In accordance with the Accounting Standard AS-21 on Consolidated
Financial Statements read with Accounting Standard AS-23 on Accounting
for Investments in Associates, your Directors provide the un-audited
Consolidated Financial Statements in the annual report,
SHARE CAPITAL
During the financial year 2005-06, the Company has allotted 7,50,000
equity shares (3,00,000 equity shares on April 9th, 2005, 2,00,000
equity shares on May 23rd, 2005 and 2,50,000 equity shares on August
31st, 2005) of Rs. 10/- each per share upon exercise of the conversion
option of 7,50,000 convertible warrants by the allottee, Dr. Jayaram
Chigurupati, Chairman and Managing Director, issued on a preferential
basis, at a price (including premium) of Rs. 55/- each
In line with the scheme of amalgamation between M/s. Credence
Pharmaceuticals Limited and M/s Hemarus Healthcare Private Limited with
the Company approved by the Honble High Court of Andhra Pradesh at
Hyderabad on May 2nd, 2006, the Company has issued 1,11,27,664 equity
shares to the erstwhile shareholders of M/s. Credence Pharmaceuticals
Limited and M/s. Hemarus Healthcare Private Limited on July 17th, 2006
in the ratio of 2:3 and 51:10, respectively However, as on March 31st,
2006 the company has created a share suspense account to the extent of
Rs. 1,112.77 lakhs.
EMPLOYEE STOCK OPTION SCHEME (ESOS)
The Company has introduced stock option plan for the employees.
However, no Options were granted under the Zenotechs Employee Stock
Option Plan for the year ended as on March 31st, 2006, Hence, the
disclosures pursuant to the provisions of Guideline 12 of the
Securities and Exchange Board of India (Employee Stock Option Scheme
and Employee Stock Purchase Scheme), Guidelines, 1999 are not provided.
DELISTING
The Companys equity shares were delisted from the Hyderabad Stock
Exchange Limited (HSE) with effect from April 12th, 2006. The Company
has also placed its delisting application from the Calcutta Stock
Exchange Association Limited (CSE) The Companys equity shares continue
to remain listed on the Bombay Stock Exchange Limited (BSE)
CORPORATE GOVERNANCE AND ADDITIONAL INFORMATION TO SHAREHOLDERS
Your Company has complied with all the mandatory recommendations of the
Narayana Murthy Committee on Corporate Governance constituted by the
Securities and Exchange Board of India (SEBI). A detailed report on
Corporate Governance system and practices of the Company are given in a
separate section in this annual report. Detailed information for the
shareholders is given in Additional Shareholders Information section.
MANAGEMENT DISCUSSION AND ANALYSIS
A detailed Management Discussion and Analysis section is provided in
this annual report.
SUBSIDIARY COMPANIES
1. The Company has a wholly owned subsidiary company, Zenotech
Farmaceutica Do Brasil Limitada (ZFDBL), Brazil. The Company was
acquired in January 2005. The Company has received ANVISA approval for
its warehouse facility in Brazil. ZLL has since filed product dossiers
with ANVISA. Further regulatory approvals are to be received before
commencement of commercial business. However, for the financial year
the company has consolidated the financials in accordance with the
IGAAP
2. The Company has a wholly owned subsidiary company, Zenotech
Laboratories Nigeria Limited (ZLNL), Nigeria. The Company was
established in August 2005. The Company is awaiting regulatory
clearances for its product range to commence commercial business.
However, for the financial year the company has consolidated the
financials in accordance with the IGAAP.
3. The Company has a wholly owned subsidiary company Zenotech Inc.,
New Jersey USA which was the wholly owned subsidiary of erstwhile M/s.
Hemarus Healthcare Private Limited. For the financial year the Company
has consolidated the financials in accordance with the IGAAP
RESPONSIBILITY STATEMENT OF THE BOARD OF DIRECTORS
In compliance of Section 217 (2AA) of the Companies Act, 1956, the
Board submits as under:
* in the preparation of the annual accounts, the applicable accounting
standards had been followed along with proper explanation relating to
material departures;
* the Directors had selected such accounting policies and applied them
consistently and made judgments and estimates that are reasonable and
prudent so as to give a true and fair view of the state of affairs of
the Company at the end of the financial year and of the profit or loss
of the Company for that period;
* the Directors had taken proper and sufficient care for the
maintenance of adequate accounting records in accordance with the
provisions of the Act for safeguarding the assets of the Company and
for preventing and detecting fraud and other irregularities;
* the Directors had prepared the annual accounts on a going concern
basis.
DEPOSITS
The Company has not accepted any deposit under Section 58A of the
Companies Act, 1956 during the year under review.
DIRECTORS
Dr. Denis Broun and Prof. Vithala R. Rao retire by rotation at the 17th
Annual General Meeting and they being eligible offers themselves for
re-appointment.
We inducted Mr. M.R. Vikram as an additional director of the Company on
November 29th, 2005, He is an Independent Non-Executive Director As
per the provisions of Section 260 of the Companies Act, 1956, Mr.
Vikram holds office only up to the date of the ensuing Annual General
Meeting of the Company The Company has received notice under Section
257 of the Act, proposing his appointment as a Director of the Company,
liable to retire by rotation, along with the requisite deposit.
Resolution seeking approval of the shareholders for his appointment has
been incorporated in the Notice convening the forthcoming Annual
General Meeting along with his brief details.
AUDITORS
M/s. Ganeshvenkat & Co., (formerly M/s. Rajavenkat & Associates),
Chartered Accountants, Statutory Auditors of your Company hold office
until the conclusion of the ensuing Annual General Meeting. They have
shown their inability to be re-appointed as the Statutory Auditors,
Therefore, the Board of Directors has proposed the appointment of M/s.
Deloitte Haskins & Sells, Chartered Accountants, as the Statutory
Auditors. The Company has received a certificate from them to the
effect that their appointment, if made, would be within the limits
prescribed under Section 224(1) of the Companies Act, 1956.
PARTICULARS OF EMPLOYEES
During the year under review, none of the employees of the Company have
drawn remuneration as specified under Section 217(2A) of the Companies
Act, 1956 read with the Companies (Particulars of Employees) Rules,
1975.
ENERGY CONSERVATION, RESEARCH AND DEVELOPMENTS, TECHNOLOGY ABSORPTION,
FOREIGN EXCHANGE EARNINGS AND OUTGO
The particulars relating to energy conservation, research and
development, technology absorption, foreign exchange earnings and
outgo, as required to be disclosed under Section 217(1)(e) of the
Companies Act, 1956 read with Companies (Disclosure of Particulars in
the Report of Board of Directors) Rules, 1988 are provided in the
Annexure to this report.
ACKNOWLEDGMENT
The Board of Directors would like to express their grateful
appreciation for the assistance and co-operation received from the
Financial Institutions and Banks like Andhra Pradesh State Financial
Corporation (APSFC), Technology Development Board (TDB), Andhra Bank,
Indian Overseas Bank (IOB), UTI Bank and other banks, Government
Authorities, Customers, Vendors and Members during the year under
review,
Yours Directors also wish to place on record the sincere efforts and
committed services put in by the employees at all levels. Our growth
was made possible by their hard work, solidarity cooperation and
support.
tor and on behalf of the Board
Place: Hyderabad Dr. Jayaram Chigurupati
Date: August 27th, 2006 Chairman and Managing Director
FORM B
Research and Development
1. Specific areas in which R&D carried out by the Company Generic Bio
Pharmaceuticals
The biotech R&D department has teams working in different areas of
product, process and formulations development, all working in synchrony
to take a biological drug product from start to commercial launch. The
four main areas of work are generic biologicals (therapeutic proteins
and monoclonal antibodies), generic formulations and drug delivery
systems, generic peptide drugs and new therapeutic humanized monoclonal
antibodies,
During the year, the generic biologicals group mainly focused on the
process scale-up and validation activities required for launching G-CSF
(Nugraf™) and GM-CSF (MacrogenTM) commercially The activities required
for scaling up the fermentation and purification processes at 100L
scale, including qualification of processes and equipments were
undertaken. Purified recombinant human Growth Hormone and Rituximab
were manufactured and sent to Pune for conducting pre-clinical animal
toxicology studies. Both these products showed no adverse reactions or
toxicology on completion of animal studies, The human clinical trial
for generic lnterleukin-2 was initiated and is now nearing completion.
This product is likely to be commercialized by the end of the year,
generic rituximab (Zenotechs first generic monoclonal antibody) is
currently awaiting regulatory approval for phase III human clinical
trials. A few more generic monoclonal antibodies are under development
including transtuzumab, which has moved from the product development
stage to pre-clinical testing approval stage.
The protein formulations group, besides developing a generic PEGylated
G-CSF (similar to Neulasta, Amgen) also developed a novel PEGylated
G-CSF, the patent for which is being filed with the Indian patent
office.
A new area of generic oncology peptides was initiated during the year
by putting in place the infrastructural requirements for synthesizing
and characterizing peptide drugs.
In the area of new drugs, two new humanized monoclonal antibodies are
being developed and are likely to enter the regulatory pathway in a
couple of months time.
Small Volume Parenterals
The synthetic API R&D division develops cost-effective processes for
manufacture of generic drug molecules. The processes for synthesis of
two molecules, Gemcitabine hydrochloride, a chemotherapy drug and
Zoledronic acid, used in hypercalcemia of malignancy, are now in use
tor regular production batches. The processes for a few chemotherapy
drugs like Docetaxel and Paclitaxel are at the scale-up stage of
development, which is likely to be followed by several other
chemotherapy molecules like Irinotecan, Oxaliplatin, and Topotecan.
These achievements are due to the efforts of a team of fifteen
qualified and experienced personnel. They operate in a 6,500 sq.ft.
area of a state-of-the-art facility equipped with the reactors, fume
hoods, rotary evaporators and pumps for conducting multi-stage
reactions.
The process development activity does not stop with the development of
a process for API bulk production. The formulation development team
takes on where the bulk team leaves of, coping with the challenges of
freeze drying and drug delivery (PEGylation, liposomal and depot
formulations). This team has been instrumental in developing new or
improved processes for formulation of several molecules in oncology and
anesthesiology, for in-house and outside customers
A highlight has been the method to manufacture multi-dose formulation
of propofol-the first of its kind in India. Among several other
challenging projects taken up by the team, a few of them deserve
special mention; the formulation development tor L-asparaginase and a
new process for the manufacture of epirubicin and bleomycin are among
them. Several process improvements instituted by the team has helped in
quality improvements of products like gemcitabine and zoledronic acid
injections. In one way or the other, the team has been responsible for
the launch of the entire anesthesiology range of products at Zenotech.
In addition to the cytotoxic and anesthesiology products, Zenotech has
developed several products in other therapy areas as well. These
products are listed in the table below and have again been the outcome
of the superior efforts of the formulations development team.
2. Benefits derived as a result of the R&D
The commercial launch of two generic recombinant protein drugs G-CSF
(Nugraf™) and GM-CSF (Macrogen™), for use by oncologists to treat
chemotherapy-induced neutropenia, was possible because of the product
and process development activities carried out by the R&D team. Besides
these two drugs, lnterleukin-2, a therapeutic used in the treatment of
renal cell carcinoma and Growth Hormone used for pediatric growth
deficiency were also developed by the in-house R&D team Development of
a novel category of generic biologicals, the monoclonal antibodies, was
initiated two years back and the first generic monoclonal antibody
developed (Rituximab) could complete pre-clinical toxicology studies,
The team that has several other monoclonal antibodies in the pipeline
for development, will soon deliver a second monoclonal antibody for
pre-clinical toxicology studies. The product and process development
activities for several generic biological molecules have been the
highlight of the achievements by the in-house R&D team. There have been
other achievements as well that cannot be disregarded, like the method
for novel pegylation of G-CSF and the initiation of new areas of work
in generic oncology peptides and novel humanized monoclonal antibodies.
All these activities are certain to not only provide a steady supply of
drugs in the pipeline, but also establish different technology
platforms within the R&D, that can be of immense value in future to the
Company
3. Future plan of action
The Company is committed to developing generic biologicals and other
speciality injectables in oncology, neurology and endocrinology Besides
developing generic recombinant proteins and monoclonal antibodies, it
also plans to foray into the area of new drugs, mainly new humanized
monoclonal antibodies. Developing generic and new formulations and drug
delivery systems are also being considered with great interest, since
this technology has immense potential to add value during
commercialization of peptide drugs. The company is actively developing
several speciality injectables for the US and EU markets. The company
will start filing ANDAs for these products in the next few months.
4. Expenditure on R&D Rs. lakhs
a. Captal 4.77
b. Recurring 213.71
c. Total 218.48
d. Total as percentage of turnover 16.56%
Technology absorption, adoption and innovation
The technologies handled by the R&D team so far were developed
completely in-house, with no collaborations or technology transfers
from outside parties
Among the four patents filed so far, two of them have already been
submitted for filing with the WIPO-PCT A fifth patent is in the
process of being filed with the Indian patent office this year.
C. Foreign Exchange Earnings and Outgo Total foreign exchange used and
earned:
Rs. lakhs
i) Foreign Exchange earnings 118.46
ii) Foreign Exchznge outgo (including raw materils components and spare
parts of 1,88.18 capital goods, investments and other expenditures in
foreign currency including dividends)
for and on behalf of the Board
Place; Hyderabad Dr. Jayaram Chigurupati
Date; August 27th, 2006 Chairman and Managing Director |
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